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Drug Safety-related Labeling Changes (SrLC)

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SABRIL (NDA-020427)

(VIGABATRIN)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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01/24/2020 (SUPPL-21)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.3       Magnetic Resonance Imaging (MRI) Abnormalities in Infants

(Additions and/or revisions underlined)

The specific pattern of signal changes observed in patients 6 years and younger was not observed in older pediatric and adult patients treated with vigabatrin. In a blinded review of MRI images obtained in prospective clinical trials in patients with refractory complex partial seizures (CPS) 3 years and older (N=656), no difference was observed in anatomic distribution or prevalence of MRI signal changes between vigabatrin treated and placebo treated patients. In the postmarketing setting, MRI changes have also been reported in patients 6 years of age and younger being treated for refractory CPS.

8 Use in Specific Populations

8.1        Pregnancy

    (Pregnancy and Lactation Labeling Rule (PLLR) conversion; please refer to label)

8.2        Lactation

(Pregnancy and Lactation Labeling Rule (PLLR) conversion; additions and/or revisions underlined)

Risk Summary

Vigabatrin is excreted in human milk. The effects of SABRIL on the breastfed infant and on milk production are unknown. Because of the potential for serious adverse reactions from vigabatrin in nursing infants, breastfeeding is not recommended. If exposing a breastfed infant to SABRIL, observe for any potential adverse effects.

8.4        Pediatric Use

(Additions and/or revisions underlined)

The safety and effectiveness of SABRIL as adjunctive treatment of refractory complex partial seizures in pediatric patients 2 to 16 years of age have been established and is supported by three double-blind, placebo-controlled studies in patients 3 to 16 years of age, adequate and well-controlled studies in adult patients, pharmacokinetic data from patients 2 years of age and older, and additional safety information in patients 2 years of age. The dosing recommendation in this population varies according to age group and is weight-based. Adverse reactions in this pediatric population are similar to those observed in the adult population.

The safety and effectiveness of SABRIL as monotherapy for pediatric patients with infantile spasms (1 month to 2 years of age) have been established.

Safety and effectiveness as adjunctive treatment of refractory complex partial seizures in pediatric patients below the age of 2 and as monotherapy for the treatment of infantile spasms in pediatric patients below the age of 1 month have not been established.

Abnormal MRI signal changes and Intramyelinic Edema (IME) in infants and young children being treated with SABRIL have been observed.

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions underlined)

Advise patients and caregivers to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).  

Administration Instructions for SABRIL Powder for Oral Solution

Physicians should confirm that caregiver(s) understand how to mix SABRIL for Oral Solution and to administer the correct dose to their infants and pediatric patients.

Pregnancy

Advise pregnant women and women of child-bearing potential that the use of SABRIL during pregnancy can cause fetal harm which may occur early in pregnancy before many women know they are pregnant. Instruct patients to notify their physician if they become pregnant or intend to become pregnant during therapy. Advise patients that there is a pregnancy exposure registry that collects information about the safety of antiepileptic drugs during pregnancy.

Nursing

Counsel patients that SABRIL is excreted in breast milk. Because of the potential for serious adverse reactions in nursing infants from SABRIL, breastfeeding is not recommended. If a decision is made to breastfeed, nursing mothers should be counseled to observe their infants for signs of vision loss, sedation and poor sucking.

07/31/2019 (SUPPL-20)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.4 Neurotoxicity

(additions underlined)

Intramyelinic edema (IME) has been reported in postmortem examination of infants being treated for IS with vigabatrin.

08/21/2018 (SUPPL-18)

Approved Drug Label (PDF)

Boxed Warning

6.2 Post Marketing Experience

(Additions and/or revisions are underlined)

Skin and Subcutaneous Tissue Disorders: Angioedema, maculo-papular rash, pruritus, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)), alopecia

04/27/2017 (SUPPL-16)

Approved Drug Label (PDF)

Boxed Warning

(Additions and/or revisions are underlined)

WARNING: PERMANENT VISION LOSS

Because of the risk of permanent vision loss, SABRIL is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Vigabatrin REMS Program. Further information is available at www.vigabatrinREMS.com or 1-866-244-8175.

5 Warnings and Precautions

5.2 Vigabatrin REMS Program

(Additions and/or revisions are underlined; subsection title revised)

SABRIL is available only through a restricted distribution program called the Vigabatrin REMS Program, because of the risk of permanent vision loss.

Notable requirements of the Vigabatrin REMS Program include the following: …

Further information is available at www.vigabatrinREMS.com, or call 1-866-244-8175.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

(Additions and/or revisions are underlined)

What is the most important information I should know about SABRIL?

  • Because SABRIL might cause permanent vision loss, it is available to healthcare providers and patients only under a special program called the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program. SABRIL can only be prescribed to people who are enrolled in this program. As part of the Vigabatrin REMS Program, it is recommended that your healthcare provider test your (or your child’s) vision from time to time (periodically) while you (or your child) are being treated with SABRIL, and even after you (or your child) stop treatment. Your healthcare provider will explain the details of the Vigabatrin REMS Program to you. For more information, go to www.vigabatrinREMS.com or call 1-866-244-8175.

06/21/2016 (SUPPL-14)

Approved Drug Label (PDF)

Boxed Warning

Additional and updated bullets:

  • SABRIL can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, SABRIL also can damage the central retina and may decrease visual acuity
  • Vision assessment is recommended at baseline (no later than 4 weeks after starting SABRIL), at least every 3 months during therapy, and about 3 to 6 months after the discontinuation of therapy.
  • Consider drug discontinuation, balancing benefit and risk, if vision loss is documented.
  • Risk of new or worsening vision loss continues as long as SABRIL is used. It is possible that vision loss can worsen despite discontinuation of SABRIL.
  • SABRIL should not be used in patients with, or at high risk of, other types of irreversible vision loss unless the benefits of treatment clearly outweigh the risks.
  • Use the lowest dosage and shortest exposure to SABRIL consistent with clinical objectives

(updated) Because of the risk of permanent vision loss, SABRIL is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the SABRIL REMS Program. Further information is available at www.SabrilREMS.com or 1-888-457-4273.

5 Warnings and Precautions

Permanent Vision Loss replaces Vision Loss – Extensive changes; please refer to label.

 

SABRIL REMS Program replaces the SABRIL SHARE Program

  • SABRIL is available only through a restricted distribution program called the SABRIL REMS Program, because of the risk of permanent vision loss.

Notable requirements of the SABRIL REMS Program include the following:

  • Prescribers must be certified by enrolling in the program, agreeing to counsel patients on the risk of vision loss and the need for periodic monitoring of vision, and reporting any event suggestive of vision loss to Lundbeck.
  • Patients must enroll in the program.
  • Pharmacies must be certified and must only dispense to patients authorized to receive SABRIL.
  • Further information is available at www.SabrilREMS.com, or call 1-888-457-4273.
Withdrawal of Antiepileptic Drugs (AEDs)

(addition of sentence) As with all AEDs, SABRIL should be withdrawn gradually. However, if withdrawal is needed because of a serious adverse event, rapid discontinuation can be considered. Patients and caregivers should be told not to suddenly discontinue SABRIL therapy.

6 Adverse Reactions

Permanent Vision Loss replaces Vision Loss

 

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MG - Permanent vision loss:

(updated) SABRIL can damage the vision of anyone who takes it. People who take SABRIL do not lose all of their vision, but some people can have severe loss particularly to their ability to see to the side when they look straight ahead (peripheral vision). With severe vision loss, you may only be able to see things straight in front of you (sometimes called “tunnel vision”). You may also have blurry vision. If this happens, it will not get better.
MG - Tell your healthcare provider right away if you (or your child):

  • (updated bullet) It is recommended that your healthcare provider test your (or your child’s) vision (including peripheral vision) and visual acuity (ability to read an eye chart) before you (or your child) start SABRIL or within 4 weeks after starting SABRIL, and at least every 3 months after that until SABRIL is stopped. It is also recommended that you (or your child) have a vision test about 3 to 6 months after SABRIL is stopped.
  • (updated bullet) Your baby should also have a vision test about 3 to 6 months after SABRIL is stopped.
MG - Tell your healthcare provider right away if you think that your baby is:

  • acting differently than normal (change SABRIL SHARE Program to SABRIL REMS Program in all instances)

 

PCI - Administration Instructions for SABRIL Powder for Oral Solution

Physicians should confirm that caregiver(s) understand how to mix SABRIL for Oral Solution and to administer the correct dose to their infants.
PCI - Permanent Vision Loss replaces Vision Loss

(update of sentence) Advise patients and caregivers that vision testing may be insensitive and may not detect vision loss before it is severe. Also advise patients and caregivers that if vision loss is documented, such loss is irreversible. Ensure that both of these points are understood by patients and caregivers.
PCI - SABRIL REMS Program (replaces SABRIL SHARE Program)

  • SABRIL is available only through a restricted program called the SABRIL REMS Program. Inform patients/caregivers of the following:
  • Patients/caregivers must be enrolled in the program.
  • SABRIL is only available through pharmacies that are enrolled in the SABRIL REMS Program.